FDA reviews Xiaflex (Auxilium Pharmaceuticals) for patients with Peyronie's disease

The FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharmaceuticals, for treatment of Peyronie's disease (PD). The FDA is expected to take action on the application by September 6, 2013. Xiaflex for the treatment of PD was granted orphan designation in the US in 1996 and if approved by the FDA is expected to be the first and only biologic therapy indicated for the treatment of PD.

The application is based on data from the IMPRESS studies and other controlled and uncontrolled clinical studies, in which over 1,000 PD patients were enrolled and received over 7,400 injections of Xiaflex. In the two identical Phase III double-blind placebo-controlled IMPRESS studies, Xiaflex demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo.